Important note: Information in this article was accurate in 1987. The state of the art may have changed since the publication date.
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Food and Drug Administration, U.S. Department of Health and Human Services - April 20, 1987
Susan Cruzan; (301) 443-3285
FDA Commissioner Frank E. Young, M.D., Ph.D., said, "This validation kit will help re-instate some previously ineligible donors and thus will increase the supply of blood available to blood banks and patients needing transfusions. The kit should increase our confidence in the accuracy of our findings."
The initial test of donated blood uses a screening test called ELISA (enzyme-linked immunosorbent assay). To protect the public, the ELISA was designed for maximum sensitivity to eliminate virtually all questionable blood and plasma. However, this increased sensitivity results in some nonspecific or false positive readings.
A test called "the Western blot" can then be performed to validate the earlier finding of a positive ELISA. Previously, the Western blot test procedure had been used in a research setting to identify specific AIDS antibodies. The Western blot kit announced today standardizes the procedure for use by blood bank personnel.
The standardization and licensing of this additional, more specific test kit can help solve a blood bank problem resulting when donors who are AIDS antibody-negative have tested falsely positive by the ELISA test. Under current guidelines, when a donor tests positive to the ELISA, his or her blood is not used for transfusion. Many of these positive ELISA tests are thought to be "false positive," due to reactions to test components (other than viral proteins) or to other technical problems.
A plan to use validation tests to reenter donors into the donor pool was discussed Feb. 13 by the FDA Blood Products Advisory Committee.
The FDA proposed a plan that involves retesting with the ELISA and Western blot on two different samples of blood taken six months apart. If all tests on the freshly drawn samples are negative (do not show antibody presence) the donor would be reentered.
FDA will soon recommend to the blood community a specific procedure for donor reentry.
Robert E. Windom, M.D., HHS assistant secretary for health, emphasized that individuals with antibody-positive Western blot results should be referred for medical evaluation, which may include additional testing. The significance of antibodies in an asymptomatic individual is not known. However, many people with AIDS virus antibodies will develop AIDS with the passage of time.
The approved Biotech/DuPont HIV Western blot kit will be manufactured by Biotech Research Laboratories, Inc. of Rockville, Md., and distributed by E.I. Du Pont de Nemours and Company of Wilmington, Del.
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SOURCE: Food and Drug Administration (FDA).
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